The Supreme Court will soon decide on a case involving access restrictions to the abortion pill Mifeprex (mifepristone). Last year, a Texas judge ruled to suspend the Food and Drug Administration’s approval of the abortion pill mifepristone in response to a lawsuit brought by a conservative coalition called the Alliance Defending Freedom. The judge did this, however, citing two now retracted studies claiming to demonstrate harms caused by the abortion pill.
Sage Journals retracted three published papers this week, including the two referenced by federal judge Matthew Kacsmaryk in a legal case against access to the abortion pill mifepristone. An investigation revealed what the publisher called “methodological flaws” and “misleading conclusions,” in addition to the authors’ undisclosed conflicts of interest.
According to Reuters, the lead author of the studies, James Studnicki, a vice president at the Charlotte Lozier Institute, rejects what he considers “baseless attacks” on the Institute’s scientific research and studies.
Based in part on findings from the retracted publications, Judge Kacsmaryk argued in the spring of 2023 that mifepristone’s original approval in 2000 by the FDA was flawed because it overlooked what he characterized as “serious safety issues” with the pill. In a highly unusual move, he then suspended the approval of mifepristone, a drug that has been on the market for more than two decades. In so doing, Kacsmaryk was siding with the party who filed the suit in Texas. The group charged that the FDA “illegally approved chemical abortion drugs.”
At the time of Kacsmaryk’s decision, the New York Times reported that the Justice Department argued it was too late to file a lawsuit challenging the FDA’s 2000 decision, owing to the statute of limitations which is six years. Because of this, the Department reasoned, the judge couldn’t void the licensing of mifepristone in 2000. Nevertheless, he could and did target the FDA’s 2021 lifting of the in-person requirement for women to obtain mifepristone after it is prescribed by a certified healthcare provider. Kacsmaryk explicitly prohibited mailing of the medication, even to states where most abortions are legal.
The judge’s preliminary injunction threatened access to the pill nationwide. But soon after Kacsmaryk’s judgement, the Supreme Court blocked the order, allowing the status quo to continue until it would take up and review the case, which it will now do next month. A decision by the Court is expected later this year.
The justices will hear an appeal from the Biden Administration and the manufacturer of the branded version of mifepristone, Mifeprex, asking for a reversal of Kacsmaryk’s ruling.
In 2000, the FDA approved mifepristone for medication abortion. Mifepristone is a drug that blocks progesterone, which is needed for a pregnancy to continue. When taken in conjunction with misoprostol, mifepristone ends early pregnancies (up to 10 weeks following conception). Medication abortion accounts for more than half of all abortions nationwide, according to the Guttmacher Institute.
Mifepristone has been in use in Europe for nearly three decades with a minimal number of adverse events. And the drug has had a similar safety record in the U.S since its approval in 2000. Between September 2000 and December 2018, 24 of the more than 3.7 million women who had undergone medicated abortions have died, according to the FDA.
And, expanding the scope of scientific publications to include other countries around the globe, at least 100 studies have examined the effectiveness and safety of mifepristone and misoprostol. Every study concluded that the pills are a safe method for terminating a pregnancy.
The FDA’s mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, the FDA is the federal authority on all pharmaceuticals distributed throughout the U.S., including mifepristone and misoprostol. On this basis, FDA approval of a drug would appear to preempt any state action.
But this is clearly not how Judge Kacsmaryk views it. Moreover, legislators and governors in some Republican-led states have argued that they can ban abortion drugs because they have the authority to regulate the practice of medicine, which may go against the FDA’s decisions. Indeed, 19 states have already prohibited telemedicine visits for abortifacients. By claiming there are “medical risks with abortion drugs” lawmakers and governors in these states maintain that there’s a “compelling interest” to impede access to mifepristone and misoprostol.
And so, while the Supreme Court will be deciding whether to permit access to mifepristone, there’s still the issue of states that defy the FDA’s authority under the guise of what they claim is regulating the practice of medicine to prevent medical risks from occurring. It would seem that no matter what the data show in terms of safety, these states will continue to restrict access to mifepristone and misoprostol. Ostensibly these limits will be imposed on the grounds of health risk, but in reality it’s on the basis of an anti-abortion stance.